CHICAGO — The voluntary withdrawal of CyPass from the global market shocked the field of ophthalmology, but the process in place worked nicely to approve the device and, in turn, take it off the market, according to a speaker here.
In August, Alcon issued a voluntary withdrawal of the of the MIGS device, citing risk for endothelial cell loss, and the FDA has subsequently identified the recall as being Class I.
“A subclinical finding was identified before clinical signs or symptoms were evident. The FDA placed a safety net and (Read more...)

Full Story →

CHICAGO — The voluntary withdrawal of CyPass from the global market shocked the field of ophthalmology, but the process in place worked nicely to approve the device and, in turn, take it off the market, according to a speaker here.
In August, Alcon issued a voluntary withdrawal of the of the MIGS device, citing risk for endothelial cell loss, and the FDA has subsequently identified the recall as being Class I.
“A subclinical finding was identified before clinical signs or symptoms were evident. The FDA placed a safety net and (Read more...)

Full Story →